CETIRIZINE HYDROCHLORIDE

Pharmacokinetics Absorption: Cetirizine was rapidly absorbed with a time to maximum concentration (T max ) of approximately 1 hour following oral administration of tablets or oral solution in adults. Comparable bioavailability was found between the tablet and oral solution dosage forms. When healthy volunteers were administered multiple doses of cetirizine (10 mg tablets once daily for 10 days), a mean peak plasma concentration (C max ) of 311 ng/mL was observed. No accumulation was observed. Ce...

Clinical Studies Multicenter, randomized, double-blind, clinical trials comparing cetirizine 5 to 20 mg to placebo in patients 12 years and older with perennial allergic rhinitis were conducted in the United States. Two of these showed significant reductions in symptoms of perennial allergic rhinitis for up to 8 weeks in duration. Two 4-week multicenter, randomized, double-blind, clinical trials comparing cetirizine 5 to 20 mg to placebo in patients with chronic idiopathic urticaria were also conducted and showed significant improvement in symptoms of chronic idiopathic urticaria. In general, ...

ADVERSE REACTIONS Pediatric studies were conducted with cetirizine hydrochloride. More than 1300 pediatric patients aged 6 to 11 years with more than 900 treated with cetirizine hydrochloride at doses of 1.25 to 10 mg per day were included in controlled and uncontrolled clinical trials conducted in the United States. The duration of treatment ranged from 2 to 12 weeks. Placebo-controlled trials up to 4 weeks duration included 168 pediatric patients aged 2 to 5 years who received cetirizine, the ...

CONTRAINDICATIONS Cetirizine hydrochloride oral solution, USP is contraindicated in those patients with a known hypersensitivity to it or any of its ingredients or hydroxyzine.